COVID-19 stimulus package gives FDA more oversight of OTC drugs

A bill that will change the way over-the-counter drugs are regulated was included in the $2 trillion stimulus package that was passed by the House March 27, Stat reported. 

The old system for regulating OTC drugs was more than 40 years old and the FDA has long been calling for it to be overhauled. 

Under the old system, the FDA couldn't approve OTC drugs before they reached the market, meaning the agency struggled to enforce basic safety requirements for the thousands of OTC products on the market. 

Despite the FDA calling for reforms, partisan disputes have previously stalled legislation to change the system, according to Stat

The bill to change the system was included in the stimulus package because the OTC industry has argued that it is a "key part" of the COVID-19 response. The industry has argued the bill will provide financial relief for consumers who have purchased supplies in response to the COVID-19 outbreak. 

The bill, which was passed by the House of Representatives March 27 and will now be sent to the president to be signed into law, will allow the FDA more stringent oversight of OTC products. 

OTC drugmakers will pay regulatory fees to the FDA to conduct product reviews and, in exchange for the money paid, the drugmakers will get 18 months of exclusivity for any new product considered innovative, according to Stat.

The bill also gives the FDA more flexibility to update its product standards for OTC products and will allow consumers without good health insurance coverage to use health savings accounts to pay for OTC drugs.

Read the full article here.

More articles on pharmacy:
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13 drugmakers form consortium to find COVID-19 treatments

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